Orthostatic HypotensionPhase 1NCT01521221
Assessment of Hand-grip in the Prevention of Postural Orthostatic Hypotension
A Phase 1 study testing Hand grip maneuver in people with Orthostatic Hypotension, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The study is aimed to assess the efficacy of hand-grip in preventing orthostatic hypotension in 20 patients diagnosed with autonomic failure. Five healthy subjects will be studied for comparison. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthostatic Hypotension
- What is being tested?
- Hand grip maneuver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2012to Apr 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Man or women
- 18 years of age or older
- Diagnosed with orthostatic hypotension due to Parkinson's disease, multiple system atrophy or pure autonomic failure
- Orthostatic hypotension is not due to drugs, any heart disorder, anemia or dehydration
Who cannot join
- Pregnant or breast feeding
Trial locations and contacts
1 site in 1 country.
Israel1 site
Movement disorders unit, the Department of Neurology, Sourasky Medical Center
Tel Aviv, 64239
Amnon Mosek, MD, 972-3-6974874, mosek@tasmc.health.gov.il
Tania Gurevitch, MD, 972-3-6974912, tanyag@tasmc.health.gov.il
About this study
The study is aimed to assess the efficacy of hand-grip in preventing orthostatic hypotension in 20 patients diagnosed with autonomic failure. Five healthy subjects will be studied for comparison. The investigators will evaluate the subjects while on tilt table for 10 minutes and than while mounted from lying down to 70 degrees for additional 10 minutes. Blood pressure, heart rate and symptoms will be continuously measured. First study will evaluate the blood pressure changes. Second measure will include hand-grip maneuver 1 minute before the erect positon. Trans cranial Doppler will assess the intracranial blood flow during the position changes.
Read the detailed description
Study 1:
10 minutes lying on the tilt table. Performing TCD study at 10 minutes. Raising the tilt table to 70 degrees. Performing TCD study 5 minutes after tilting. Measuring blood pressure and symptoms for 10 minutes. Returning the tilt bed to supine position.
Study 2. in continue with study 1:
10 minutes lying on the tilt table. Performing TCD study at 10 minutes. Performing hand-grip at 50-70% grip force for 1 minute Raising the tilt table to 70 degrees. Performing TCD study 5 minutes after tilting. Measuring blood pressure and symptoms for 10 minutes. Returning the tilt bed to supine position.
- Conditions
- Orthostatic Hypotension
- Being tested
- Hand grip maneuver
- Medical subject headings
- Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand grip maneuverOther
Hand grip on blood pressue cuff slightly inflated at 50-70% of maximal force for 1 minute
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Patients with autonomic failure. Receives: Other: Hand grip maneuver |
| Healthy subjects | Experimental | Control group Receives: Other: Hand grip maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in orthostatic blood fall after tilting with and without hand grip.
Patients will be tilted to 70 degrees twice. Hand grip maneuver will be performed 1 minute before the second tilt study and the differences in blood pressure changes [baseline-end tilt (mmHg)] will be compared between the two studies and to those obtained from a healthy control group.
Measured: 10 minutes after tilting the subjects.
Secondary outcomes (1)
Change in the intracranial blood flow after tilting with and without hand grip.
Intracranial blood flow will be evaluated by transcranial doppler at baseline and after tilting. Differences will be compared [peak systolic flow (PSW) cm/sec], after tilting with and without prior hand grip and in comparison to tilting a control group.
Measured: 10 minutes after tilting.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2012 (estimated)
- Study startApr 2012
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthostatic HypotensionStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Amnon Mosek, MD, Principal investigator, Deputy Chief, the Department of Neurology, Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01521221
- Sponsor's protocol ID
- TASMC-08-AM-462-CTIL
- Status last verified
- Jan 2012
- First submitted
- 15 Aug 2011
- Last updated
- 30 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Hand-grip in the Prevention of Postural Orthostatic Hypotension
- ClinicalTrials.gov ID
- NCT01521221
- Acronym / sponsor ID
- TASMC-08-AM-462-CTIL
- Conditions
- Orthostatic Hypotension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Apr 2012
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 30 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is aimed to assess the efficacy of hand-grip in preventing orthostatic hypotension in 20 patients diagnosed with autonomic failure. Five healthy subjects will be studied for comparison. The investigators will evaluate the subjects while on tilt table for 10 minutes and than while mounted from lying down to 70 degrees for additional 10 minutes. Blood pressure, heart rate and symptoms will be continuously measured. First study will evaluate the blood pressure changes. Second measure will include hand-grip maneuver 1 minute before the erect positon. Trans cranial Doppler will assess the intracranial blood flow during the position changes.
Detailed description
Study 1:
10 minutes lying on the tilt table. Performing TCD study at 10 minutes. Raising the tilt table to 70 degrees. Performing TCD study 5 minutes after tilting. Measuring blood pressure and symptoms for 10 minutes. Returning the tilt bed to supine position.
Study 2. in continue with study 1:
10 minutes lying on the tilt table. Performing TCD study at 10 minutes. Performing hand-grip at 50-70% grip force for 1 minute Raising the tilt table to 70 degrees. Performing TCD study 5 minutes after tilting. Measuring blood pressure and symptoms for 10 minutes. Returning the tilt bed to supine position.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Other: Hand grip maneuverPatients with autonomic failure. |
| Healthy subjects | Experimental | Other: Hand grip maneuverControl group |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Man or women
- 18 years of age or older
- Diagnosed with orthostatic hypotension due to Parkinson's disease, multiple system atrophy or pure autonomic failure
- Orthostatic hypotension is not due to drugs, any heart disorder, anemia or dehydration
Key exclusion criteria (1 listed)
- Pregnant or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand grip maneuverHand grip on blood pressue cuff slightly inflated at 50-70% of maximal force for 1 minute | Other | Healthy subjects, Patients |
Primary outcome
Change in orthostatic blood fall after tilting with and without hand grip.
Time frame: 10 minutes after tilting the subjects.
Patients will be tilted to 70 degrees twice. Hand grip maneuver will be performed 1 minute before the second tilt study and the differences in blood pressure changes [baseline-end tilt (mmHg)] will be compared between the two studies and to those obtained from a healthy control group.
1 secondary outcome
Change in the intracranial blood flow after tilting with and without hand grip.
Time frame: 10 minutes after tilting.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Movement disorders unit, the Department of Neurology, Sourasky Medical Center
Tel Aviv, Israel
Amnon Mosek, MD principal investigator
Deputy Chief, the Department of Neurology, Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hand grip maneuver in people with Orthostatic Hypotension, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in orthostatic blood fall after tilting with and without hand grip. (time frame: 10 minutes after tilting the subjects.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2012.